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What is ketoconazole?

Ketoconazole is an antifungal antibiotic.

Ketoconazole is used to treat infections caused by fungus, which can invade any part of the body including the mouth, throat, esophagus, lungs, bladder, or skin.

Ketoconazole may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about ketoconazole?

You should not use this medication if you are allergic to ketoconazole, or if you are also taking cisapride (Propulsid) or triazolam (Halcion). Other drugs that should not be taken together with ketoconazole include astemizole (Hismanal) and terfenadine (Seldane) (these drugs are no longer available in the U.S.).

Before taking ketoconazole, tell your doctor if you have liver disease, kidney disease, a heart rhythm disorder, decreased stomach acid (achlorhydria), or a history of "Long QT syndrome."

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ketoconazole will not treat a viral infection such as the common cold or flu.

Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) for at least 2 hours after you have taken your dose of ketoconazole. These medications can make it harder for the ketoconazole tablet to dissolve in your stomach.

Avoid drinking alcohol. It may cause unpleasant side effects while you are taking ketoconazole.

What should I discuss with my healthcare provider before taking ketoconazole?

You should not use this medication if you are allergic to ketoconazole, or if you are also taking cisapride (Propulsid) or triazolam (Halcion). Other drugs that should not be taken together with ketoconazole include astemizole (Hismanal) and terfenadine (Seldane) (these drugs are no longer available in the U.S.).

Before taking ketoconazole, tell your doctor if you are allergic to any drugs, or if you have:

decreased stomach acid (achlorhydria);

liver disease;

kidney disease;

a heart rhythm disorder; or

a personal or family history of "Long QT syndrome."

If you have any of these conditions, you may need a dose adjustment or special tests to safely take ketoconazole.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Ketoconazole may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take ketoconazole?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Ketoconazole works best if you take it with food. Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ketoconazole will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your liver function may need to be checked with blood tests on a regular basis. Do not miss any scheduled appointments.

Store ketoconazole at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a ketoconazole overdose are not known.

What should I avoid while taking ketoconazole?

Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) for at least 2 hours after you have taken your dose of ketoconazole. These medications can make it harder for the ketoconazole tablet to dissolve in your stomach.

Avoid drinking alcohol. It may cause unpleasant side effects while you are taking ketoconazole.

Ketoconazole side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Ketoconazole Dosing Information

Usual Adult Dose for Oral Thrush:

Initial dose: 200 mg orally once a day.May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 1-2 weeks.

Usual Adult Dose for Dermatophytosis:

Initial dose: 200 mg orally once a day.May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 4 weeks.

Usual Adult Dose for Blastomycosis:

Initial dose: 200 mg orally once a day.May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for at least 6 months.

Usual Adult Dose for Coccidioidomycosis:

Initial dose: 200 mg orally once a day.May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for at least 6 months.

Usual Adult Dose for Histoplasmosis:

Initial dose: 200 mg orally once a day.May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for at least 6 months.

Usual Adult Dose for Paracoccidioidomycosis:

Initial dose: 200 mg orally once a day.May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for at least 6 months.

Usual Adult Dose for Chronic Mucocutaneous Candidiasis:

Initial dose: 200 mg orally once a day.May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 3-12 months. Patients usually require maintenance therapy.

Usual Adult Dose for Esophageal Candidiasis:

Initial dose: 200 mg orally once a day.May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 2-3 weeks.

Usual Adult Dose for Onychomycosis -- Fingernail:

Initial dose: 200 mg orally once a day.May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 6-12 months.

Usual Adult Dose for Onychomycosis -- Toenail:

Initial dose: 200 mg orally once a day.May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 6-12 months.

Usual Adult Dose for Vaginal Candidiasis:

Initial dose: 200 mg orally once a day.May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for approximately 1 to 2 weeks and until tests indicate the resolution of the infection.

Usual Pediatric Dose for not applicable:

Infants and children: 3.3-6.6 mg/kg orally once a day for 2-4 weeks.Prophylaxis for recurrence of mucocutaneous candidiasis with HIV infections: 5-10 mg/kg/day divided every 12-24 hours to a maximum of 800 mg/day divided in two doses

What other drugs will affect ketoconazole?

Many drugs can interact with ketoconazole. Below is just a partial list. Tell your doctor if you are using:

This list is not complete and there are many other drugs that can interact with ketoconazole. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ketoconazole.

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